ice OUtcomes for Referrals with Impulsivity, Self Harm and Eating Disorders: The NOURISHED Study

Not Applicable

Completed

Conditions: Eating disorders/borderline personality disorder
Mental and Behavioural Disorders
Eating disorders

Registration Number: ISRCTN51304415

Lead Sponsor: Barnet Enfield and Haringey Mental Health Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 140

Inclusion Criteria

1. Aged over 18 years, either sex
2. Eating disorder diagnosis
3. Borderline personality disorder (BPD) symptoms. The criteria for BPD symptoms are that the patient fulfils both behavioural criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), namely:
3.1. Impulsivity in at least two areas that are potentially self-damaging (e.g., spending, sexual behaviour, substance abuse, reckless driving, binge eating)
3.2. Recurrent suicidal behaviour, or self-mutilating behaviour
4. Able and willing to provide written informed consent

Exclusion Criteria

1. Current psychosis
2. Current inpatient
3. Currently in psychological therapy
4. Received mentalisation-based treatment (MBT) less than 6 months prior to randomisation
5. Organic brain disease leading to significant cognitive impairment
6. Body mass index (BMI) less than 15 kg/m2 (normal range 19 - 25 kg/m2, anorexia nervosa less than 17.5 kg/m2)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eating disorder symptoms will be measured 6-monthly using the global score of the Eating Disorder Examination (Time points: 0, 6, 12, 18 months)

Secondary Outcome Measures

Name	Time	Method
1. Borderline Personality Disorder symptoms will be measured 6-monthly using the total score of the ZAN-BPD (Time points 0, 6, 12, 18 months)<br>2. The economic evaluation will examine the costs-effectiveness of Mentalization Based Therapy and Specialist Supportive Clinical Management including an analysis of incremental cost per QALY<br>3. Participant rated general psychiatric symptoms of Borderline Personality Disorder will be measured 6-monthly using the DASS-21 (Time points 0, 6, 12, 18 months)<br>4. Possible mediators of change in Borderline Personality Disorder symptoms include reflective function and object relations, measured by the Reflective Function Questionnaire, The Reading the Mind in the Eyes test and the Object Relations Inventory and personality factors (e.g. resilience, dysregulation, restriction) thought to be important in Eating Disorders (Time points 0, 6, 12, 18 months)